The Advancing Patient Safety Coalition wrote to members of the House Energy and Commerce Committee to ask them to include patient safety language in the Medical Device User Fee Amendments of 2007 legislation, crafted by Reps. Mike Doyle (D-Penn.) and Darlene Hooley (D-Ore.). The language requires the Food and Drug Administration to move forward on regulations establishing a national unique device identification (UDI) system for medical devices and requiring devices to be labeled with a unique identifier.
“Unlike medications, and virtually every other product in commerce, medical devices cannot be identified in a systemic and consistent manner,” the letter says. “The resulting ad hoc approach results in increased clinical risks to patients.” That includes implanting a defective, counterfeit or recalled product, inability to track the recipient of a faulty product, and inability to track adverse events appropriately.
More than 600 medical devices are recalled each year.